EyeBOX

Primary DI
00810051680003
Brand
EyeBOX
Company
Oculogica Inc.
Model
OCL 02.5
Device description
Oculogica’s EyeBOX uses eye-tracking technology and a data processing algorithm to detect subtle changes in eye movements resulting from concussion. The eye tracking task involves watching a video move around the perimeter of an LCD monitor positioned in front of the patient while a high speed near- infrared (IR) camera records gaze positions. The post-processed data are analyzed automatically to produce one or more outcome measures. The device is comprised of a host PC with integrated touchscreen interface for the operator, eye tracking camera, LCD stimulus screen and head-stabilizing rest (chin rest and forehead rest) for the patient, and data processing algorithm.The EyeBOX device tracks a patient’s eye movement and calculates a BOX Score ranging from 0-20. A score of less than 10 is a negative result, while a score of greater than or equal to 10 indicates a positive result.
Published
2021-09-21
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
QEABrain Injury Adjunctive Interpretive Oculomotor Assessment Aid

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QEABrain Injury Adjunctive Interpretive Oculomotor Assessment AidNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K201841000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K201841000EyeBOXOculogica, Inc.2020-09-06QEA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810051680003PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810051680003008100516800038100516800030810051680003

GMDN Terms#

Term, Definition table
TermDefinition
Eye-tracking brain injury assessment deviceAn electrically-powered unit intended to measure and analyse eye movement to assist in the diagnosis/assessment of potential brain injury (e.g., concussion). It includes visual stimuli (e.g., videos) and devices for sensing/tracking (e.g., infrared cameras) eye movement, dedicated software for analysing results and providing management guidelines, and a user interface for viewing/input. It is intended to be used by a healthcare professional in a clinical setting. This is a reusable device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Atmospheric Pressure70 KiloPascal106 KiloPascal
Handling Environment Humidity30 Percent (%) Relative Humidity75 Percent (%) Relative Humidity
Handling Environment Temperature10 Degrees Celsius30 Degrees Celsius
Storage Environment Atmospheric Pressure70 KiloPascal106 KiloPascal
Storage Environment Humidity30 Percent (%) Relative Humidity75 Percent (%) Relative Humidity
Storage Environment Temperature10 Degrees Celsius40 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
078866200
Device count
1
Lot or batch
true
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810051680010EyeBOXDMR-00042026-05-19

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810051680010EyeBOXOculogica Inc.QEA2026-05-19
00860013612900EYE-SYNCNEUROSYNC INC.QEA2025-03-12